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| [January 10, 2013] |
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Clearside Biomedical Announces Plans for Clinical Testing of CLS1001 (Triamcinolone Acetonide) Suprachoroidal Injectable Suspension for the Treatment of Some Eye Diseases
ALPHARETTA, Ga. --(Business Wire)--
Clearside Biomedical, Inc., a privately held ophthalmic company
developing and commercializing targeted therapeutics for the treatment
of sight threatening diseases, announced today that the standard 30-day
review period by the U.S. Food and Drug Administration (FDA) relating to
Clearside's Investigational New Drug (IND) Application for CLS1001
(triamcinolone acetonide) Suprachoroidal Injectable Suspension for the
treatment of sympathetic ophthalmia, temporal arteritis, uveitis and
ocular inflammatory conditions unresponsive to topical corticosteroids
has concluded and clinical testing can proceed.
Clearside Biomedical, Inc. treats the pathological changes to the blood
retinal barrier that lead to retinal blindness by delivering
therapeutics through the suprachoroidal space using a proprietary
microinjection dosage form. This microinjection process allows eye care
professionals to treat patients in their offices without complicated
sugical techniques. Clearside Biomedical accomplishes targeted drug
delivery to the site of disease through a proprietary microinjection
platform that allows compartmentalization within the distinct areas of
the eye, such as retina and posterior segment via the suprachoroidal
space. Clearside Biomedical is currently targeting the initiation of a
Phase 1-2 clinical trial in the US in first quarter 2013 to evaluate the
safety and tolerability of the product candidate in subjects with
non-infectious uveitis.
"Our initial data showed that the microinjection platform is a viable
technique for delivering drugs to the retina and choroid within the
current standards of medical practice," said Daniel White, President and
CEO of Clearside Biomedical. "We're looking forward to making progress
in this important next step."
About Clearside Biomedical
Clearside Biomedical, based in Alpharetta, is a clinical-stage
ophthalmic pharmaceutical company developing and commercializing
targeted therapeutics for the treatment of sight-threatening diseases.
Clearside treats the pathological changes to the blood retinal barrier
that lead to retinal blindness by delivering therapeutics through the
suprachoroidal space using a proprietary microinjection dosage form.
Clearside Biomedical was founded by an executive team with extensive
development and revenue growth expertise focused on improving the
delivery and performance of therapeutic agents to improve the standard
of care for patients with retinal and choroidal disease. Visit http://www.clearsidebio.com/
for more information.

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